Comparison of Sensimed Triggerfish (TF) 24 Hour Monitoring of the Eye in Glaucoma Patients Before and After Trabeculectomy

NCT04000828 | Completed

• 1 other identifier: 2019-14131
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

A 24 hour profile is recorded using Sensimed Triggerfish in glaucoma patients before and after Trabecuelctomy

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Amplitude

  Comparison of Amplitude between the preoperative Triggerfish Profile and the Triggerfish Profile three months after Trabeculectomy

  up to 14 weeks

Secondary Outcomes (1)

• Correlation of other parameters

  up to 14 weeks

Study Arms (1)

single Arm

OTHER

all patients receive the measurement with Sensimed Triggerfish

Device: Placement of Sensimed Triggerfish

Interventions

Placement of Sensimed Triggerfish DEVICE

Sensimed Triggerfish is placed on the corneal surface

single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must have the willingness and ability to provide signed informed consent
• Patient is able to comply with the study procedure
• Patient must be ≥ 18 years old
• Diagnosis of primary open angle glaucoma (EGS criteria) including pseudoexfoliation glaucoma/ normal tension glaucoma/ pigmentary glaucoma in the study eye
• planned trabeculectomy in the study eye
• in preparation for trabeculectomy, all preoperative IOP lowering medication has been replaced by Dorzolamid 20 mg/ml + Timolol 5mg/ml preservative free eye drops in the study eye for at least 28 days before Triggerfish® profile
• Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out
• Visual Acuity of 20/200 or better in both eyes
• Ability of subject to understand the character and individual consequences of the study

You may not qualify if:

• Subjects with contraindications for wearing contact lenses in the study eye
• secondary glaucoma in the study eye
• History of refractive surgery in the study eye
• History of intraocular surgery in the last three months in the study eye
• Severe dry eye syndrome as judged by the investigator in the study eye
• Keratoconus or other corneal abnormalities
• Any other abnormality in the study eye, that prevents the safe placement of the device after investigators decision
• Conjunctival or intraocular inflammation in the study eye
• Simultaneous participation in other clinical trials
• Previous IOP-lowering intervention in the study eye
• Current shift workers (applicable for at least 3 months)
• Transmeridian flight \< 2 months before screening (6 hours time shift)
• Subjects with pacemaker

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Study Sites (1)

Clinical Trial Site, Department of Ophthalmology, University Medical Center Johannes Gutenberg University Mainz

Mainz, 55131, Germany

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of clinical trial site

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: June 27, 2019
• Study Start: May 22, 2019
• Primary Completion: April 14, 2020
• Study Completion: April 14, 2020
• Last Updated: September 1, 2021

Record last verified: 2021-08

Locations

DE (1)